UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Virginia 54-1972729 (State or other jurisdiction of incorporation or organization) (I.R.S. employer identification no.) 700 US Highway 202/206, Bridgewater, New Jersey 08807 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...

Wall Street analysts forecast that Insmed (INSM) will report quarterly loss of -$1.30 per share in its upcoming release, pointing to a year-over-year increase of 33%. It is anticipated that revenues will amount to $103.42 million, exhibiting an increase of 14.5% compared to the year-ago quarter. The current level reflects a downward revision of 1.1% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their i ...

Wall Street expects a year-over-year increase in earnings on higher revenues when Insmed (INSM) reports results for the quarter ended June 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 7. On the o ...

Core Viewpoint - Insmed Incorporated will release its second-quarter 2025 financial results on August 7, 2025, and will host a conference call for investors to discuss these results and provide a business update [1][2]. Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for patients with serious diseases, with a diverse portfolio of approved and investigational medicines [4]. - The company is advancing programs primarily in pulmonary and inflammatory conditions, including a therapy approved in the U.S., Europe, and Japan for a chronic lung disease [4]. - Insmed's early-stage programs involve various technologies such as gene therapy, AI-driven protein engineering, and synthetic rescue [4]. Conference Call Details - The conference call for investors will begin at 8:00 a.m. ET on August 7, 2025, and can be accessed via phone or webcast [2]. - A replay of the conference call will be available approximately one hour after its completion until August 14, 2025 [3].

Core Insights - Insmed Inc experienced a significant stock surge of 45% in the last month, driven by successful Phase IIb trial results for its inhalation therapy TPIP in pulmonary arterial hypertension (PAH) [2] - The company is currently trading at a high valuation of 35 times sales, which translates to a low sales yield of 2.8%, raising concerns about its sustainability [3] - Insmed's stock premium is primarily attributed to the positive trial results and a $750 million capital raise aimed at pipeline expansion, leading to investor optimism [4][5] Financial Performance - Insmed projects global revenues for its product ARIKAYCE to be between $405 million and $425 million in 2025, indicating an 11-17% growth compared to 2024 [6] - The company is expected to remain unprofitable into 2026 due to ongoing investments in research and development for pipeline products [6] Future Outlook - The FDA's decision on brensocatib in August and the initiation of Phase 3 trials for TPIP are critical upcoming milestones that could significantly impact Insmed's stock performance [7] - Successful execution of Phase 3 trials and commercial launches of both brensocatib and TPIP will be essential for maintaining the current premium valuation [7][8]

Core Viewpoint - Insmed Incorporated has announced a public offering of 7,812,500 shares of common stock at a price of $96.00 per share, aiming to raise approximately $750 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The public offering is priced at $96.00 per share, with gross proceeds expected to be around $750 million [1]. - Insmed has granted underwriters a 30-day option to purchase an additional 1,171,875 shares [1]. - The offering is expected to close on June 13, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds will be used to fund research and development of brensocatib, pre-commercial and commercialization activities related to brensocatib, and further development of ARIKAYCE® [2]. - Additional funds will support the research and development of treprostinil palmitil inhalation powder (TPIP), INS1201, and other pre-clinical research product candidates, as well as general corporate purposes including business expansion [2]. Group 3: Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases, with a diverse portfolio of approved and investigational medicines [6]. - The company is advancing programs primarily in pulmonary and inflammatory conditions, including a therapy approved in the U.S., Europe, and Japan for a chronic lung disease [6]. - Insmed's research includes a variety of technologies such as gene therapy, AI-driven protein engineering, and synthetic rescue [6].

Core Viewpoint - Insmed Incorporated plans to offer and sell $650 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $97.5 million more [1] Group 1: Offering Details - The public offering is subject to market conditions and there is no assurance regarding the completion or terms of the offering [1] - Goldman Sachs & Co. LLC and Leerink Partners are acting as joint book-running managers for the offering [2] - The offering is made pursuant to Insmed's shelf registration statement on Form S-3, which became effective on May 19, 2023 [3] Group 2: Company Overview - Insmed is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases [5] - The company has a diverse portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions [5] - Insmed's advanced programs include a therapy approved in the U.S., Europe, and Japan for a chronic lung disease [5] - The company is headquartered in Bridgewater, New Jersey, with offices and research locations in the U.S., Europe, and Japan [6]

Group 1 - The group caters to both novice and experienced biotech investors, providing insights on catalysts, buy and sell ratings, and product sales forecasts for major pharmaceutical companies [1] - The group offers integrated financial statements, discounted cash flow analysis, and market-by-market analysis to aid investment decisions [1] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the investing group Haggerston BioHealth and has compiled detailed reports on more than 1,000 companies [1]

Core Insights - Insmed Incorporated announced positive topline results from its Phase 2b study of treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension (PAH), meeting both primary and secondary efficacy endpoints [1][3] Group 1: Study Results - The primary endpoint showed a placebo-adjusted reduction in pulmonary vascular resistance (PVR) of 35%, with a Least Squares mean ratio of 0.65 [1] - The secondary endpoint indicated a placebo-adjusted improvement in six-minute walk distance (6MWD) of 35.5 meters [2] - A significant placebo-adjusted reduction of 60% in N-terminal pro-b-type natriuretic peptide (NT-proBNP) concentrations was observed, with an LS mean ratio of 0.40, indicating the therapeutic effect's durability [3] Group 2: Future Plans - Insmed plans to engage with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 trial for PAH and aims to initiate a Phase 3 trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 [4] - A Phase 3 trial for PAH is expected to start in early 2026, with TPIP therapy being well tolerated in the study [4] Group 3: Analyst Opinions - Bank of America Securities (BofA) noted that TPIP data exceeded expectations, highlighting its potential to become foundational in PAH/PH-ILD treatment [5] - BofA raised its price forecast for Insmed from $94 to $109, maintaining a Buy rating, while other analysts also increased their price targets, reflecting strong confidence in the company's prospects [6][7][8]

Core Insights - Insmed's shares increased nearly 29% following the positive results from a phase IIb study of its investigational drug TPIP for pulmonary arterial hypertension (PAH) [1] Group 1: Study Results - The study met its primary endpoint, showing a statistically significant reduction of 35% in pulmonary vascular resistance (PVR) for TPIP-treated participants [2] - All secondary efficacy endpoints were also met, with a placebo-adjusted improvement in six-minute walk distance (6MWD) of 35.5 meters and a 60% reduction in NT-proBNP concentrations [3] Group 2: Future Plans - Insmed plans to engage with the FDA to design a late-stage study for TPIP in PAH, aiming to start this study in early 2026 [4] - The company intends to present detailed study results at a future medical meeting [4] Group 3: Disease Context - PAH is a rare, progressive disease affecting nearly 90,000 patients in the U.S., Europe, and Japan, characterized by high blood pressure in the pulmonary arteries [5] Group 4: Competitive Landscape - Insmed is also developing TPIP for pulmonary hypertension associated with interstitial lung disease (PH-ILD), with late-stage trials planned for the second half of 2025 [9][10] - TPIP's once-daily dosing could provide a competitive advantage over United Therapeutics' Tyvaso, which requires multiple daily doses [11][12] Group 5: Market Impact - The positive data from Insmed led to a 14% decline in United Therapeutics' stock price, as well as a 17% decline in Liquidia Corporation's stock, indicating potential long-term headwinds for their inhaled treprostinil products [13][14]